To Assess the Effect of Renal Impairment on the Blood Levels of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325 After Multiple Doses of a Fixed Dose Combination Tablet

Hepatitis C Clinical Trial

Official title:

An Open-label, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Fixed Dose Combination Formulation of DCV, ASV, and BMS-791325 in Subjects With Normal Renal Function and Subjects With Mild, Moderate, Severe, and End-stage Renal Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02108639
• Other study ID #: AI443-110
• Status: Completed
• Phase: Phase 1
• First received: April 7, 2014
• Last updated: July 9, 2014
• Start date: April 2014
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Assess the effect of renal function on the blood levels of DCV, ASV, BMS-791325.

Description:

IND Number: 79,599/101,943

Primary Purpose: Other - Phase 1 Clinical Pharmacology study to determine the effect of renal impairment on the exposure of DCV, ASV, BMS-791325 (fixed dosed combination) and BMS-791325 given in multiple doses

Fixed dose combination (FDC)

Fixed Dose Combination of Daclatasvir, Asunaprevir and BMS-791325 (DCV 3DAA FDC)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Subjects in Group A must be in good health and have normal renal function

• Subjects in Groups B-E may have clinical, Electrocardiogram (ECG) and laboratory findings consistent with their degree of renal dysfunction

• Women of childbearing potential (WOCBP) and male participants must agree to follow the required contraceptive methods

Exclusion Criteria:

• Subjects in Group A must not have any significant acute or chronic illnesses

• Subjects in Groups B-E must not have uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, and/or neurological disease within 6 months of screening

• Subjects in Groups B-E may not have evidence of rapidly deteriorating renal function, defined as a screening creatinine clearance (CLcr) which has decreased from a previous CLcr by 50% within the last 3 months

• Prior exposure to DCV, ASV or BMS-791325 within 3 months prior to study drug administration

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hepatitis C

Intervention

Drug:
• DCV 3DAA FDC

• BMS-791325

Locations

Country	Name	City	State
United States	New Orleans Center For Clinical Research - Knoxville	Knoxville	Tennessee
United States	Clinical Pharmacology Of Miami Inc.	Miami	Florida
United States	Davita Clinical Research	Minneapolis	Minnesota
United States	Orlando Clinical Research Center	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax) for DCV, ASV, BMS-791325 and BMS-794712		For Groups A-D: Day 1 to Day 10 and for Group E: Day 1 to Day 12	No
Primary	Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) for DCV, ASV, BMS-791325 and BMS-794712		For Groups A-D: Day 1 to Day 10 and for Group E: Day 1 to Day 12	No
Secondary	Concentration at 12 hours (C12) for (DCV, ASV, BMS-791325) and BMS-948158		For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13	No
Secondary	Time of maximum observed concentration (Tmax) for (DCV, ASV, BMS-791325) and BMS-948158		For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13	No
Secondary	Apparent total body clearance (CLT/F) for (DCV, ASV and BMS-791325 only)		For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13	No
Secondary	Trough observed plasma concentration (Ctrough) for (DCV, ASV, BMS-791325), BMS-794712 and BMS-948158		For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13	No
Secondary	Cmax fraction unbound (Cmaxfu) for (DCV, ASV, BMS-791325), BMS-794712 and BMS-948158	BMS-948158 may also be analyzed	For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13	No
Secondary	AUC(TAU) fraction unbound (AUC(TAU) fu) for (DCV, ASV, BMS-791325), BMS-794712 and BMS-948158	BMS-948158 may also be analyzed	For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13	No
Secondary	Protein Binding for DCV, ASV, BMS-791325 and BMS-794712		1 and 4 hours postdose on Day 10 (all subjects) and Day 12 (Group E only)	No
Secondary	Total amount recovered in urine (URt) for (DCV, ASV, BMS-791325) and BMS-794712		For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13	No
Secondary	Total percent of administered dose recovered in urine (%URt) for (DCV, ASV, and BMS-791325 only)		For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13	No
Secondary	Renal clearance (CLR) for DCV, ASV, BMS-791325, and BMS-794712		For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13	No
Secondary	Maximum observed concentration (Cmax) for BMS-948158		For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13	No
Secondary	Area under the concentration-time curve in 1 dosing interval (AUC (TAU)) for BMS-948158		For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13	No
Secondary	Safety based on occurrence of Adverse Event (AEs), Serious adverse event (SAEs) and AEs leading to discontinuation		For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13	Yes
Secondary	Safety based on abnormalities in vital sign measurements		For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13	Yes
Secondary	Safety based on findings on ECG measurements and physical examinations		For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13	Yes
Secondary	Safety based on Marked abnormalities in clinical laboratory test findings		For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13	Yes

External Links

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